Before a new drug can be approved for sale to the public, governmental agencies require proof that the drug is safe for use and effective in treating some condition. To establish this, drug companies conduct tests of the drug. These tests may involve giving the drug to animals and measuring the result. However, where the drug is intended for humans, a final phase in the testing process is the conducting of clinical trials in which the drug is administered to humans and the results are measured. These tests are expensive and time consuming to design and carry out. If errors are made during the tests, the resulting data may be useless, and the test may have to be repeated, delaying the ultimate approval of the drug, resulting in lost income to the drug company, and the additional expense of repeating the tests.
In order to ameliorate the potential for flawed clinical trials, various companies offer software that is intended to help manage these tests. For example, the Fraser Williams Company of Birmingham, UK, sells its Impact software for this purpose. IBM sells a program called ClinWare for the same purpose. The programs Sitebase from Parexel International Corporation of Boston, Mass.; and e.Power Clinical by Universal Systems Inc. of Chantilly, Va., all serve similar purposes.
It frequently occurs that a clinical trial for a new drug will be conducted at multiple locations nationally and internationally. This helps to test the drug on diverse populations, to assess environmental differences, and to spread the burden of locating and managing a large number of people who will become the test subjects of the trial. Since laws governing clinical tests vary from country to country, the administrative management of the protocol for the trial may have to be tracked differently, yet the administrative data must be sufficiently uniform for it to be combined into total trial management results. Further, the administrative data from the different sites of the trial must be integrated in an efficient way into a single database. However, providing access to this database from around the world and by numerous users, can lead to performance degradation, e.g., slow performance and problems with access. Prior systems do not adequately address this problem.
While the prior systems allow for the design of linear trials, it may be that a protocol requires split treatment, depending on the subject's response to the drug during treatment. In particular, if the early outcome is one result the treatment is governed by procedure A, and is governed by procedure B if the result is otherwise. The prior systems cannot adequately plan and track and display such complex trials.
The prior systems require extensive maintenance to input information on the personnel and medications available for the clinical trial. Consequently, methods for reducing the data input requirements would be beneficial. Further, information in one trial may be the same as information in another trial, but be identified with a different name. Similarly, information given the same name can be very different. Management of this nomenclature and definition problem is particularly important in situations where there is a need to combine the planning and tracking results of several trials.
The development of protocols for clinical trials is an ongoing procedure. Thus, there is a need to be able to easily modify a protocol to include new requirements. It should also be easy to tailor a global protocol to meet country and site requirements. Most prior systems lack this degree of flexibility.